ImportRefusal LogoImportRefusal

HEIEN LARSSEN AS

⚠️ Moderate Risk

FEI: 3025370855 • Spikkestad • NORWAY

FEI

FEI Number

3025370855

📍

Location

Spikkestad

🇳🇴

Country

NORWAY
🏢

Address

Industriveien 7, , Spikkestad, , Norway

Moderate Risk

FDA Import Risk Assessment

38.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
1
Unique Violations
2/14/2023
Latest Refusal
1/17/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
41.8×20%
Frequency
30.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1183×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
2/14/2023
73ECXCYLINDER, COMPRESSED GAS, AND VALVE
118NOT LISTED
Division of Southeast Imports (DSEI)
2/14/2023
73ECXCYLINDER, COMPRESSED GAS, AND VALVE
118NOT LISTED
Division of Southeast Imports (DSEI)
1/17/2023
79PQNCARBON DIOXIDE GAS CONTROLLED TISSUE EXPANDER
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HEIEN LARSSEN AS's FDA import refusal history?

HEIEN LARSSEN AS (FEI: 3025370855) has 3 FDA import refusal record(s) in our database, spanning from 1/17/2023 to 2/14/2023.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. HEIEN LARSSEN AS's FEI number is 3025370855.

What types of violations has HEIEN LARSSEN AS received?

HEIEN LARSSEN AS has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about HEIEN LARSSEN AS come from?

All FDA import refusal data for HEIEN LARSSEN AS is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.